Banana Boat Kids Mineral Vanishing Green Foam Spf 50 Amazing Apple

Banana Boat Kids Mineral Vanishing Green Foam Spf 50 Amazing Apple
SPL v2
SPL
SPL Set ID bf4c47c4-2045-8b4c-e053-2a95a90afc5f
Route
TOPICAL
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (49 mg) Zinc Cation (71 mg)
Inactive Ingredients
Tricaprin Vinylpyrrolidone/eicosene Copolymer Water Isobutane Medium-chain Triglycerides Isohexadecane Butyloctyl Salicylate Sodium Chloride Ethylhexyl Methoxycrylene Dimethicone Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol Polyethylene Glycol 400 Caprylyl Glycol Aluminum Oxide Glycerin Sodium Citrate .alpha.-tocopherol Acetate D&c Yellow No. 11 D&c Green No. 6 Peg-8 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01

Description

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings

For external use only - Do not consume.

May stain or damage some fabrics or surfaces.

Directions
  • Shake well 
  • Dispense in upright position for optimal results
  • Hold container 4 to 6 inches from the skin to apply 
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Do not spray directly into face. Spray on hands then apply to face 
  • Do not apply in windy conditions 
  • Use in well-ventilated area 
  • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours 
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses  Sun Protection Measures.
  • Children under 6 months: Ask a doctor.
Do Not Use

on damaged or broken skin.

Drug Facts

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Inactive Ingredients

Water, Isobutane, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, PEG-8, Caprylyl Glycol, Alumina, Fragrance, Glycerin, Sodium Citrate, Tocopheryl Acetate, Yellow 11, Green 6.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Warnings

For external use only - Do not consume.

May stain or damage some fabrics or surfaces.

Directions
  • Shake well 
  • Dispense in upright position for optimal results
  • Hold container 4 to 6 inches from the skin to apply 
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Do not spray directly into face. Spray on hands then apply to face 
  • Do not apply in windy conditions 
  • Use in well-ventilated area 
  • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours 
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses  Sun Protection Measures.
  • Children under 6 months: Ask a doctor.
Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Inactive Ingredients

Water, Isobutane, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, PEG-8, Caprylyl Glycol, Alumina, Fragrance, Glycerin, Sodium Citrate, Tocopheryl Acetate, Yellow 11, Green 6.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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